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70岁以上高危不稳定型心绞痛患者的经皮介入治疗与冠状动脉搭桥手术对比

Percutaneous intervention versus coronary bypass surgery for patients older than 70 years of age with high-risk unstable angina.

作者信息

Ramanathan Kodangudi B, Weiman Darryl S, Sacks Jerome, Morrison Douglass A, Sedlis Steven, Sethi Gulshan, Henderson William G

机构信息

Veterans Administration Medical Center, Memphis, Tennessee, USA.

出版信息

Ann Thorac Surg. 2005 Oct;80(4):1340-6. doi: 10.1016/j.athoracsur.2005.03.057.

Abstract

BACKGROUND

The Angina With Extremely Serious Operative Mortality Evaluation (AWESOME) study was a multicenter Veterans Affairs randomized trial and registry that compared long-term survival of percutaneous coronary intervention with coronary artery bypass graft surgery for the treatment of patients with medically refractory myocardial ischemia and at least one additional risk factor for an adverse outcome with bypass. Both the randomized trial and the registry demonstrated comparable 3-year survival. The purpose of this study was to compare bypass and percutaneous intervention survival of AWESOME patients who were older than 70 years of age.

METHODS

Over a 5-year period (1995 to 2000), 2,431 patients with medically refractory myocardial ischemia and at least one of the following five risk factors (prior heart surgery, myocardial infarction within 7 days, left ventricular ejection fraction less than 35%, age > 70 years, intraaortic balloon pump requirement to stabilize) were identified. Of these patients, 1,278 were older than 70 years of age. Eight hundred, seventy-one patients were turned down by at least one physician, 407 were acceptable to both physician and surgeon for randomization, and 236 (60%) consented to randomization. Of the 1,042 eligible patients who were not randomized, 871 had their revascularization directed by a physician who was not involved in the study. One hundred, seventy-one patients who were acceptable for randomization by both the interventional cardiologist and the cardiac surgeon refused consent.

RESULTS

Bypass and percutaneous intervention survival were compared using Kaplan-Meier curves and log rank tests. Bypass and percutaneous intervention 36-month survival rates for patients older than 70 years of age were 76% and 75%, respectively, among the eligible patients. Survival was 71% and 78% among those patients who were randomized and 76% and 67% in the physician-directed subgroup. Of those patients who chose their revascularization techniques, the survivals were 79% and 85%, respectively. The survival differences are not large, and none of the global log rank tests of bypass compared with percutaneous intervention survival showed a statistically significant difference over 5 years.

CONCLUSIONS

Both the randomized and registry subgroups of patients who were older than 70 years of age support the trial conclusions that either bypass or percutaneous intervention effectively relieves medically refractory ischemia among high-risk unstable angina patients whose age was greater than 70 years.

摘要

背景

“手术死亡率极高的心绞痛评估(AWESOME)”研究是一项多中心退伍军人事务部随机试验和登记研究,比较了经皮冠状动脉介入治疗与冠状动脉旁路移植术治疗药物难治性心肌缺血且至少有一项旁路手术不良结局额外危险因素患者的长期生存率。随机试验和登记研究均显示3年生存率相当。本研究的目的是比较70岁以上AWESOME患者的旁路手术和经皮介入治疗的生存率。

方法

在5年期间(1995年至2000年),确定了2431例药物难治性心肌缺血且具有以下五个危险因素中至少一项的患者(既往心脏手术、7天内心肌梗死、左心室射血分数低于35%、年龄>70岁、需要主动脉内球囊泵稳定病情)。其中,1278例患者年龄大于70岁。871例患者被至少一名医生拒绝,407例患者医生和外科医生均认为可随机分组,236例(60%)同意随机分组。在1042例未随机分组的合格患者中,871例患者的血运重建由未参与研究的医生指导。171例介入心脏病学家和心脏外科医生均认为可随机分组的患者拒绝同意。

结果

使用Kaplan-Meier曲线和对数秩检验比较旁路手术和经皮介入治疗的生存率。在合格患者中,70岁以上患者的旁路手术和经皮介入治疗36个月生存率分别为76%和75%。随机分组患者的生存率分别为71%和78%,医生指导亚组的生存率分别为76%和67%。在那些选择血运重建技术的患者中,生存率分别为79%和85%。生存差异不大,旁路手术与经皮介入治疗生存率的整体对数秩检验在5年期间均未显示出统计学显著差异。

结论

70岁以上患者的随机分组和登记亚组均支持试验结论,即旁路手术或经皮介入治疗均可有效缓解年龄大于70岁的高危不稳定型心绞痛患者的药物难治性缺血。

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